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Skin Efficacy and Tolerability of a Cosmetic Product Combination Over 3 Months in Subjects With Atopic Eczema (AtoCare-OS)

Primary Purpose

Atopic Dermatitis, Eczema-Prone Skin

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Body Lotion and Intensive Care
Sponsored by
Bionorica SE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atopic Dermatitis

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Written Informed Consent of the subject to participate in the study, or, for underaged subjects of the parents/ legal guardians to let their child participate in the study Willingness to actively participate in the study and to come to the scheduled visits or, for underaged subjects, willingness of the parents/ legal guardians to actively support their child's participation in the study and to come to the scheduled visits with their child Female and/or male Children from 2 to 17 years of age and adult subjects between 18 and 75 years of age Eczema-prone skin and atopic dermatitis, diagnosed by the dermatologist Exclusion Criteria: Female subjects (only of childbearing age): Pregnancy or lactation Drug addicts, alcoholics (only adults) AIDS, HIV-positive or infectious hepatitis Conditions which exclude a participation or might influence the test reaction/evaluation Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years Insulin-dependent diabetes mellitus One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases Documented allergies to cosmetic products and/or ingredients, skin care and/ or skin cleansing products as well as to ingredients of the test products Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids, cyclosporine, dupilumab) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac, ibuprofen), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study Any topical medicinal products (e.g. topical corticosteroids, calcineurin inhibitors) at the test area within the last 5 days prior to the start of the study Any topical medication at the test area throughout the entire course of the study (except the medication normally used for treatment of atopic eczema)

Sites / Locations

  • SGS proderm GmbH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Body Lotion BNO 3732 + Intensive Care BNO 3731

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in objective dermatological evaluation of skin status (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping) by dermatologist (min = 0, max = 3; 3 = worst outcome) to Day 29, Day 57 and Day 85
Change from baseline in Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM, (min = 0, max = 3; 3 = worst outcome) to Day 29, Day 57 and Day 85
Change from baseline in Recap of atopic eczema (RECAP, min = 0, max = 4; 4 = worst outcome) to Day 29, Day 57 and Day 85
Change from baseline in Dermatology Life Quality Index (DLQI, 10 closed questions with varying scales) to Day 29, Day 57 and Day 85

Secondary Outcome Measures

Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (no scales) to Day 29, Day 57 and Day 85
Evaluation of product traits via questionnaire (7 questions with different answers, no scales) on day 1 and after 29, 57, 85 days
Sub-group: mean change from baseline in transepidermal water loss (g/m2h), Lipid contents (ng/133mm²) and Morphological analysis (length of lipid lamellae, nm/1.000nm²) to Day 85
Safety of BNO 3732 and BNO 3731 measured by reported Adverse Events to Day 85
Subject diary (frequency of flare-ups, required physician visits, required drug administration/use of cortisone, well-being)

Full Information

First Posted
March 15, 2023
Last Updated
March 28, 2023
Sponsor
Bionorica SE
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1. Study Identification

Unique Protocol Identification Number
NCT05790083
Brief Title
Skin Efficacy and Tolerability of a Cosmetic Product Combination Over 3 Months in Subjects With Atopic Eczema
Acronym
AtoCare-OS
Official Title
Assessment of the Short- and Long-Term Skin Efficacy and Tolerability of a Cosmetic Product Combination of Body Lotion and Intensive Care Over 3 Months in Subjects With Atopic Eczema
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bionorica SE

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this exploratory study is to investigate the short- and long-term efficacy and tolerability of a cosmetic product combination consisting of a body lotion and an intensive care product in subjects with atopic eczema over 3 months of use. Efficacy is assessed by instrumental measurements of skin condition (sub-panel), clinical examinations, and questionnaires.
Detailed Description
The objective of this exploratory study is to investigate the short- and long-term efficacy and tolerability of a cosmetic product combination consisting of a body lotion and an intensive care product in subjects with atopic eczema over 3 months of use. For efficacy and tolerability evaluation, an objective dermatological assessment will be performed, in addition to assessing efficacy, the severity of atopic eczema will be assessed using the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). Further, the effect of the test product combination on symptom severity, disease control (recap of atopic eczema (RECAP)), quality of life and well-being will be evaluated by the subjects or the subjects' parents/ legal guardians. The subjects or the subjects' parents/ legal guardians will also document the frequency of flare-ups, required physician visits and the use of cortisone administration as well as their/ their child's well-being in a diary. Additionally, the influence of the test product combination on the skin barrier will be assessed in a sub-panel with dry legs by measuring the transepidermal water loss by Aquaflux and by sampling of biological material for analysis of skin lipids and corneocyte maturity before and after 3 months of product use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema-Prone Skin

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Trade name of products was masked
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Body Lotion BNO 3732 + Intensive Care BNO 3731
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Body Lotion and Intensive Care
Intervention Description
Body Lotion, applied twice daily on whole body, for 3 months. Intensive Care, applied as needed on affected body areas.
Primary Outcome Measure Information:
Title
Change from baseline in objective dermatological evaluation of skin status (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping) by dermatologist (min = 0, max = 3; 3 = worst outcome) to Day 29, Day 57 and Day 85
Time Frame
85 days of treatment
Title
Change from baseline in Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM, (min = 0, max = 3; 3 = worst outcome) to Day 29, Day 57 and Day 85
Time Frame
85 days of treatment
Title
Change from baseline in Recap of atopic eczema (RECAP, min = 0, max = 4; 4 = worst outcome) to Day 29, Day 57 and Day 85
Time Frame
85 days of treatment
Title
Change from baseline in Dermatology Life Quality Index (DLQI, 10 closed questions with varying scales) to Day 29, Day 57 and Day 85
Time Frame
85 days of treatment
Secondary Outcome Measure Information:
Title
Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (no scales) to Day 29, Day 57 and Day 85
Time Frame
85 days of treatment
Title
Evaluation of product traits via questionnaire (7 questions with different answers, no scales) on day 1 and after 29, 57, 85 days
Time Frame
85 days of treatment
Title
Sub-group: mean change from baseline in transepidermal water loss (g/m2h), Lipid contents (ng/133mm²) and Morphological analysis (length of lipid lamellae, nm/1.000nm²) to Day 85
Time Frame
85 days of treatment
Title
Safety of BNO 3732 and BNO 3731 measured by reported Adverse Events to Day 85
Time Frame
85 days of treatment
Title
Subject diary (frequency of flare-ups, required physician visits, required drug administration/use of cortisone, well-being)
Time Frame
85 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Written Informed Consent of the subject to participate in the study, or, for underaged subjects of the parents/ legal guardians to let their child participate in the study Willingness to actively participate in the study and to come to the scheduled visits or, for underaged subjects, willingness of the parents/ legal guardians to actively support their child's participation in the study and to come to the scheduled visits with their child Female and/or male Children from 2 to 17 years of age and adult subjects between 18 and 75 years of age Eczema-prone skin and atopic dermatitis, diagnosed by the dermatologist Exclusion Criteria: Female subjects (only of childbearing age): Pregnancy or lactation Drug addicts, alcoholics (only adults) AIDS, HIV-positive or infectious hepatitis Conditions which exclude a participation or might influence the test reaction/evaluation Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years Insulin-dependent diabetes mellitus One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases Documented allergies to cosmetic products and/or ingredients, skin care and/ or skin cleansing products as well as to ingredients of the test products Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids, cyclosporine, dupilumab) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac, ibuprofen), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study Any topical medicinal products (e.g. topical corticosteroids, calcineurin inhibitors) at the test area within the last 5 days prior to the start of the study Any topical medication at the test area throughout the entire course of the study (except the medication normally used for treatment of atopic eczema)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrin Unbereit, Dr.
Organizational Affiliation
proDERM GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
SGS proderm GmbH
City
Schenefeld
ZIP/Postal Code
22869
Country
Germany

12. IPD Sharing Statement

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Skin Efficacy and Tolerability of a Cosmetic Product Combination Over 3 Months in Subjects With Atopic Eczema

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